Please note: AABB reserves the right to make updates to this program.
Wednesday, August 20, 2025
2:00 – 3:00 PM Eastern Time
Program Number: 25EL-565
Director: Jennifer Chain, PhD, CABP, Consultant, CSM Consulting, LLC, Norman, OK
Moderator: Daniela Hermelin, MD, CABP, Chief Medical Officer, ImpactLife Blood Center, Earth City, MO
Speakers:
For more than 60 years, cell therapies have focused on autologous treatments derived from a patient’s own cells, including the current FDA-approved cell-based therapies. FDA regulations and accreditation standards in cell therapy were developed predominantly around the collection, manufacture, and infusion of therapies derived from patient cells and tissues. However, there are now over 100 companies developing allogeneic therapies derived from the cells of healthy donors, with over 500 clinical trials underway. This indicates a significant shift toward off-the-shelf therapies where the cellular starting material (CSM) is collected from healthy donors and manufactured into a therapy for dozens of patients.
Organizations collecting blood-derived CSM from healthy donors for use in the manufacture of CAR T therapies are unsure as to whether they should be following regulations and standards for donor-derived blood products or patient-derived tissue products. Recent draft guidance from the FDA for CAR T therapy manufacture has created additional confusion as to whether the blood-derived CSM should be treated like a blood product or tissue product. Both collectors of CSM and developers of allogeneic cell therapies are seeking more consistent guidance and understanding from the FDA and accrediting bodies on the requirements of donor-derived CSM that feed into the manufacture of clinical products. Should healthy donors be qualified and tested based on blood product or tissue product regulations? How should the blood products be handled and processed, stored and shipped if being used in CAR T therapy manufacture? Collection of CSM is the first step in manufacturing, so these questions need more consistent answers to create the most applicable regulatory standards for this exploding allogeneic cell therapy industry.
In this eCast, faculty will review the different types of CSM and their therapeutic applications. They will discuss the FDA’s definition of blood products and tissue products, then dive deep into the current state of the FDA regulations for these products and draft guidance issued for CAR T therapy developers that relates to the collection of CSM from healthy donors. Through participation in this eCAST, the faculty hope you leave with a better understanding of how to apply the existing and future regulatory framework to the collection and use of donor-derived CSM for allogeneic cell-based treatments.
After participating in this educational activity, participants should be able to:
Registration includes access to both the live and on-demand version of this eCast.
If you are a facility interested in participating in this eCast, simply complete the Group Viewing registration form and AABB will provide detailed instructions to share with your team approximately one week prior to the live program (each team member to register for the program utilizing a promocode). For single viewers, simply click on the Register button below to register.
Please note: registration for the live eCast will close 1 hour prior to the eCast start time. If you register after this time, you will receive access to the on-demand eCast when it is available.
| Single Viewer | Register |
| Group Viewing | Register |
This activity is eligible for one (1) continuing education credit/contact hour for Physicians, Nurses (including California-based nursing professionals through CBRN), California Lab Personnel, Florida Lab Personnel and General Participation credit. AABB reserves the right to reduce or increase the number of credits granted based on the final activity duration. For more information on each credit type please visit our Continuing Education Credits webpage.
There is no financial support for this activity.
In support of improving patient care, this activity has been planned and implemented by the Association for the Advancement of Blood & Biotherapies (AABB) and CME Outfitters, LLC. CME Outfitters LLC. is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Physicians (ACCME): CME Outfitters, LLC, designates this live activity for a maximum of one (1) AMA PRA Category 1 CreditTM. CME Outfitters, LLC, designates this enduring activity for a maximum of one (1) AMA PRA Category 1 CreditTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Claiming Credit
Live Activity - Upon completion of the live activity, you will receive instructions to complete your evaluation, which is necessary to claim credit and receive your certificate of attendance/completion (credit must be claimed by the date provided in the instructions). The evaluation can be found by logging into the AABB Education Platform.
Enduring Activity - Once the enduring (on-demand) program is available, you will receive instructions to access the AABB Education Platform. Upon completion of viewing the enduring activity, you will need to complete the evaluation, which is necessary to claim credit and receive your certificate of completion (credit must be claimed by the date provided in the AABB Education Platform).
Program & Credit Expiration Dates:
Disclosure Declaration
It is the policy of CME Outfitters, LLC, and the Association for the Advancement of Blood & Biotherapies to ensure independence, balance, objectivity, and scientific rigor and integrity in all of their CE activities. Faculty must disclose to the participants any relationships with commercial companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. CME Outfitters, LLC, has evaluated, identified, and mitigated any potential conflicts of interest through a rigorous content validation procedure, use of evidence-based data/research, and a multidisciplinary peer review process. The following information is for participant information only. It is not assumed that the presence of such relationships will have a negative impact on the presentations.
Disclosures for the planners of this event can be found here. Disclosures for the program faculty, peer reviewers, and CME Outfitters, LLC. personnel are provided at the beginning of the program.
Dr. Jennifer Chain earned a PhD in Microbiology and Immunology from University of Oklahoma Health Sciences Center and is a certified cellular therapy expert with 26 years of experience in T cell immunology, product development, blood banking, and consulting. As Director of Research and Development at the Oklahoma Blood Institute, she led efforts to collect cellular starting material from over 1000 healthy donors for early-stage cell therapy companies. Her collaborative leadership and innovative donor recruitment strategies in this role were instrumental in serving the allogeneic cellular therapy industry. Serving as Chief Scientific Officer for Cytogrowth Solutions, Dr. Chain played a crucial role in the development of manufacturing procedures for blood- and cell-based culture materials. These contributions helped advance allogeneic cell therapies through process innovations and new product development. Dr. Chain also works as a consultant, helping blood centers and cell therapy companies develop procurement programs and screening strategies. She actively serves the Association for the Advancement of Blood and Biotherapies (AABB), where she engages in educational, strategic planning, and advocacy efforts in cellular therapy on both national and international levels.
Dr. Daniela Hermelin is Chief Medical Officer at ImpactLife, an Assistant Professor of Pathology at St. Louis University School of Medicine and the Medical Director of Transfusion Services at SSM Health St. Louis University Hospital and SSM Health Cardinal Glennon Children’s Hospital. Dr. Hermelin completed a residency in Anatomic and Clinical Pathology in 2019, followed by a fellowship in Transfusion Medicine at SSM Health St. Louis University Hospital. A passionate educator, Dr. Hermelin was the recipient of the AABB 2019 President’s Award recognizing her use of social media to share her knowledge in the fields of Blood Banking and Transfusion Medicine with students and fellow practitioners. Dr. Hermelin serves as the Social Media Editor for Transfusion Medicine Reviews as well as an Associate Editor of The Blood Bank Guy Essentials Podcast and Transfusion News. Additionally, Dr. Hermelin is an active member of numerous professional associations including the Association for the Advancement of Blood and Biotherapies (AABB), The American Society for Apheresis (ASFA). The College of American Pathologists (CAP), American Society for Clinical Pathology, and the International Society of Blood Transfusion (ISBT).
Jared Schuster, BS, HTL(ASCP), CABP is a Senior Regulatory Affairs Associate supporting the National Marrow Donor Program and the Be the Match BioTherapies Division. He holds responsibility for a variety of regulatory functions, including submissions for various NMDP-Sponsored INDs, regulatory support of Cell and Gene Therapy manufacturer protocols as well as regulatory oversight of laboratory testing programs. Jared brings over 10 years of experience in the biotechnology space, having held scientific, quality, regulatory and project management roles throughout his career. In his current role at the NMDP, Jared focuses on development of protocols for biotherapy developers regarding the procurement of compliant cellular starting material for further manufacture, in addition to oversight of compliance considerations for the NMDP’s transplant operations. Previously, he served as a translational research scientist for a small CRO, supporting Sponsors through assay development and biomarker validation in a CLIA environment. His academic work at the University of Minnesota focused on development of anti-inflammatory and anti-fibrotic therapies for patients suffering from chronic viral infections. Jared is an active member of RAPS, ASCP, AABB and the ISCT. He graduated from the University of Minnesota with degrees in Molecular Genetics and Pharmacology, and holds certification as both a histotechnologist (ASCP) and Advanced Biotherapies Professional (AABB).
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